Intacs for Keratoconus

Study ID
Intacs Protocol_Version 1.0

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Dallas Veteran's Affairs Medical Center
  • UT Southwestern Ambulatory Services

Contact
Janie Burroughs
214/645-2012
janie.burroughs@utsouthwestern.edu

Principal Investigator
Steven Verity, M.D.

Official Title

INTACS® Prescription Inserts Used to Treat Patients With Keratoconus as a Humanitarian Use Device

Brief Overview


The US food and Drug Administration (FDA) originally approved INTACS prescription inserts in
April 1999 for the correction of low levels of nearsightedness (-1.00 to -3.00 diopters).
Additional clinical data have shown that INTACS are safe for the treatment of keratoconus,
in July 2004, FDA approved INTACS inserts for the treatment of keratoconus as a Humanitarian
Use Device (FDA approval letter attached). The statute and the implementing regulation of
FDA (21 CFR 814.124 (aj) require IRB review and approval before a HUD is used.INTACS
prescription inserts are composed of two clear segments, each having an arc length of 150┬░,
they are manufactured form a biomedical material called polymethylmethacrylate (PMMA) and
are available in three thicknesses. Two INTACS inserts ranging from 0.250mm to 0.350mm may
be implanted depending on the orientation of the cone and the amount of myopia and
astigmatism to be reduced.

Summary


The INTACS procedure is typically performed in an outpatient setting. The two tiny INTACS
inserts are surgically placed into the periphery of the cornea through a tiny cut that is
made on the cornea after numbing drops have been applied. A specially designed instrument
creates a tunnel by separating the tissue layers in the outside periphery of the cornea, the
INTACS inserts are placed into this tunnel where they remain. One or two ophthalmic sutures
will be placed to close the incision. A postoperative care information booklet will be given
to the patients; patients will be followed by means of postoperative appointments for up to
12 months after the surgery. The visits/testing schedules are listed below:

Pre-OR visit (1.5 hours): Visual Acuity (VA), Refraction, Topography, Keratometry, Glare
Test. Mesopic Pupil Size, Pachymetry, Tonometry, Slit Lamp Exam and Contrast Sensitivity.

Surgery (30min): At Laser Center for Vision Care which is part of Aston and department of
Ophthalmology.

Post-OR Day 1(10min): VA, Slit Lamp Exam.

Post-OR 1week (20min): Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 1 month (20minj: Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 3 month (1.5 hours): Some as pre-op Visit.

Post-OR 6 month (20min): Visual Acuity, Refraction, Topography, Tonometry, Slit Lamp Exam.

Post-OR 12 month (1.5 hours): Same as pre-op.

Participant Eligibility


Inclusion Criteria:

Who have experienced a progressive deterioration in their vision, such thot they can no
longer achieve adequate functional vision on a daily basis with their contact lenses or
spectacles; Who are 21 years of age or older; Who have clear central corneas; Who have a
corneal thickness of 450 microns or greater at the proposed incision site; Who have
corneal transplantation as the only remaining option to improve their functional vision.

Exclusion Criteria:

Who have abnormally thin corneas or who have a corneal thickness of 449 microns or less at
the proposed incision site;

Patients with collagen vascular, autoimmune or immunodeficiency disease;

Pregnant or nursing patients;

Presence of ocular conditions, such as recurrent corneal erosion syndrome or corneal
dystrophy, that my predispose the patient to future complications;

Patients who are taking on or more of following medications: isotretinoin (Accutane);
amiodarone HCL (Cordarone).